NIH Collaboratory Trials Archives - Rethinking Clinical Trials

April 7, 2026: Enrollment Begins for AIM-CP and RAMP Pragmatic Trials

Posted on April 7, 2026April 8, 2026 by Damon Seils

Two of the NIH Collaboratory Trials began enrollment last week. Congratulations to the study teams from AIM-CP and RAMP for reaching this important project milestone!

AIM-CP (Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain) is testing the implementation of a care management model to address disparate access to nonpharmacological treatments for chronic pain in rural populations. The program includes care coordination, cognitive behavioral therapy, and referral to a virtual exercise program. The study is led by principal investigators Sebastian Tong and Kushang Patel of the University of Washington.

The AIM-CP study team recently reported the results of a pilot study showing that their integrated nurse care management model is a feasible and effective way to deliver nonpharmacological chronic pain treatment to patients in rural communities. Learn more about AIM-CP.

Headshots of Diana Burgess, Roni Evans, and Katherine Hadlandsmyth — Diana Burgess, Roni Evans, and Katherine Hadlandsmyth, principal investigators for RAMP

RAMP (Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention) is evaluating the use of a 9-week mind-body skills training program for rural veterans with pain within the VA’s Whole Health initiative, including a one-on-one session with a health coach followed by weekly group sessions that include prerecorded expert-led education videos, mind-body skills training and practice, and group discussions. The principal investigators are Diana Burgess and Roni Evans of the University of Minnesota and Katherine Hadlandsmyth of the University of Iowa.

A recently published pilot study allowed the research team to identify several strategies to optimize the RAMP intervention for the full-scale randomized trial, including strategies to reduce participant burden and improve retention and tailor the program to the rural veteran experience. Learn more about RAMP.

Both AIM-CP and RAMP are supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by grants administered by the National Institute of Nursing Research.

April 2, 2026: In FM-TIPS Pragmatic Trial, Adding TENS to Physical Therapy Improved Fibromyalgia Pain

Posted on April 2, 2026April 2, 2026 by Damon Seils

Headshots of Dr. Kathleen Sluka and Dr. Leslie Crofford — Dr. Kathleen Sluka and Dr. Leslie Crofford, principal investigators for FM-TIPS

Adding transcutaneous electrical nerve stimulation (TENS) to physical therapy reduced pain for patients with fibromyalgia, according to the FM-TIPS pragmatic clinical trial.

The results of the study were published online in JAMA Network Open.

FM-TIPS, an NIH Collaboratory Trial, examined whether the addition of TENS to routine outpatient physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. TENS is a noninvasive, nondrug therapy that delivers low-voltage electrical currents through electrodes placed on the skin.

The study was led by principal investigators Kathleen Sluka of the University of Iowa and Leslie Crofford of Vanderbilt University.

"TENS is a safe, effective treatment for movement-evoked pain and fatigue in individuals with fibromyalgia," Sluka said."It is an inexpensive and readily available treatment that individuals can use at home to help manage their pain," she added.

The study team randomly assigned 28 outpatient physical therapy clinics in 6 healthcare systems to provide either physical therapy plus TENS or physical therapy alone to patients enrolled in the study. Across the participating clinics, 384 patients completed baseline data collection from February 2021 through September 2024 and completed final data collection by March 2025. Patients in the TENS group were instructed to apply the electrodes to the upper and lower back and wear them for 2 hours per day with a minimum of 30 minutes per session.

FM-TIPS logo After 60 days, movement-evoked pain was significantly lower among patients receiving physical therapy plus TENS compared with patients receiving physical therapy alone. In an extension of the study from day 60 to day 180, patients in the physical therapy only group began receiving TENS and patients in the TENS group continued with the treatment. At 180 days, 81% of patients reported finding TENS to be helpful and 55% were still using it daily.

Read the full article.

"The NIH Collaboratory was essential in helping the study team to design and execute FM-TIPS; we could not have done it without their continued consultation and support," Sluka said.

FM-TIPS is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Learn more about FM-TIPS.

March 24, 2026: Study Design Paper Published for Chat 4 Heart Health

Posted on March 24, 2026 by Damon Seils

Dr. Michael Ho and Dr. Sheana Bull, principal investigators for Nudge The study design paper for Chat 4 Heart Health has been published online in Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The Chat 4 Heart Health trial is testing the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors, including physical activity and medication adherence. The study will provide evidence regarding the best population-based strategy for universal delivery to engage patients in self-management to improve the American Heart Association’s “Life’s Essential 8” measures for improving and maintaining cardiovascular health.

The study is being led by Mike Ho of Kaiser Permanente Colorado and Sheana Bull of the Colorado School of Public Health and is supported by a grant award from the National, Heart, Lung, and Blood Institute.

Read the full study design paper.

March 9, 2026: AIM-CP Nurse Care Management Program Shows Promise for Rural Patients With Chronic Pain

Posted on March 9, 2026March 9, 2026 by Damon Seils

A pilot study of the AIM-CP intervention showed that an integrated nurse care management model is a feasible and effective way to deliver nonpharmacological chronic pain treatment to patients in rural communities. The findings will inform a full-scale randomized controlled trial to evaluate the intervention’s impact on a larger scale.

The results were published online ahead of print in Pain Medicine.

Rural residents experience higher rates of chronic pain but often lack access to evidence-based alternatives to opioids, such as cognitive behavioral therapy and exercise therapy. AIM-CP, an NIH Collaboratory Trial led by principal investigators Sebastian Tong and Kushang Patel of the University of Washington, will test a virtual nurse care management model that includes care coordination, cognitive behavioral therapy, and referral to a virtual exercise program.

The pilot study, conducted with 29 participants across healthcare systems in Washington and North Carolina, showed the intervention was feasible and had a high level of acceptability to patients. Participants experienced significant reductions in pain interference and improved satisfaction with their health. While adherence to nurse-led sessions was strong, the researchers observed low uptake for the exercise component, a challenge the team plans to address through enhanced training and support in the larger randomized trial.

AIM-CP is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Institute of Nursing Research. Learn more about AIM-CP.

February 24, 2026: Pragmatic Clinical Trials Offer Unique Opportunities to Study Implementation Processes and Outcomes

Posted on February 24, 2026February 24, 2026 by Karen Staman

The interventions tested in pragmatic clinical trials are embedded into routine care practices, which offers opportunities to study implementation and sustainment outcomes.

In an article published online ahead of print in Implementation Science Communications, members of the NIH Pragmatic Trials Collaboratory’s Implementati on Science Core share the results of a survey about the measurement of implementation outcomes in pragmatic trials.

Of the 32 NIH Collaboratory Trials, 29 completed the survey (91% response rate).

Main findings:

Across the trials, measurement was high for some constructs, including:

Reach (91%)
Adherence (76%)
Fidelity (93%)
Adaptations (69%)

However, evaluation for some constructs remains low:

Costs (31%)
Clinician adoption and representativeness (45%)
Anticipated sustainment (24%)
Actual sustainment (38%)

The authors suggest there is opportunity for growth in measuring some of these important implementation constructs.

“To benefit from the substantial investment into pragmatic clinical trials, we need to improve measurement of constructs that drive the implementation of evidence into routine care, including information about costs, sustainability, and sustainment,” the authors wrote.

Measurement of these constructs in future pragmatic trials could result in development of improved implementation strategies to increase the likelihood of effective implementation leading to equitable, sustainable, and scalable improvement in practice.

Read the full article.

For more information about implementation in pragmatic clinical trials, see the Living Textbook Chapter on Implementation.

February 19, 2026: RAMP Pilot Study Supports Telehealth Mind-Body Program for Rural Veterans With Chronic Pain

Posted on February 19, 2026February 19, 2026 by Damon Seils

A pilot study of the RAMP intervention suggests that a multimodal, telehealth-delivered intervention is both feasible and acceptable for rural veterans experiencing chronic pain. The findings demonstrate how mind-body and exercise strategies can be successfully delivered to populations that typically face significant barriers to specialized care.

The article was published online ahead of print in Contemporary Clinical Trials.

RAMP, an NIH Collaboratory Trial, is evaluating the use of a mind-body skills training program for rural veterans with chronic pain within the Department of Veterans Affairs (VA) Whole Health initiative.

Veterans living in rural areas experience a higher prevalence of chronic pain than their urban counterparts but often lack access to nonpharmacologic treatments due to travel distances and a shortage of local providers. While the VA has prioritized nonpharmacologic self-management, these programs remain underused among patients in rural areas and patients from marginalized groups. The RAMP intervention was designed to overcome these obstacles by providing a comprehensive self-management program directly to veterans in their homes.

The pilot study enrolled 40 rural VA patients with moderate to severe chronic pain. The intervention consisted of 12 telehealth sessions facilitated by trained health coaches. The sessions included an initial individual session to set personal health goals; 11 weekly group sessions featuring expert-led educational videos, physical exercises, and mind-body skill-building; and instruction in cognitive behavioral strategies, mindfulness, and pain-specific mobility exercises.

The pilot study met several key milestones for feasibility and acceptability. Ninety percent of participants expressed satisfaction with the intervention, and 82% stated they would recommend the program to other veterans with chronic pain. The facilitators successfully delivered 100% of the planned session activities, demonstrating high fidelity to the RAMP program model.

Participants reported that RAMP enhanced their capabilities, opportunities, and motivation to manage their pain. Specifically, the participating veterans felt more confident in their ability to handle “flare-ups,” manage stress, and incorporate physical activity into their daily lives.

“Pilot results demonstrated that RAMP is feasible and acceptable to rural Veterans with chronic pain,” the authors concluded. Because the program uses nonclinician health coaches, it has the potential to be easily integrated into existing VA clinical workflows to reach millions of rural-dwelling veterans.

The research team identified several strategies to optimize the RAMP intervention for a larger, upcoming randomized trial. To reduce participant burden and improve retention, the team plans to shorten the program from 12 to 9 weeks, provide more examples tailored to the rural veteran experience, and introduce text message reminders.

Read the full report.

The RAMP trial is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Institute of Nursing Research.

Learn more about RAMP.

January 26, 2026: New Findings From GRACE Trial Highlight Strategies for Integrating Acupuncture and Guided Relaxation Into Sickle Cell Disease Clinics

Posted on January 26, 2026January 22, 2026 by Damon Seils

GRACE Trial logo New qualitative findings from the GRACE trial reveal critical barriers and facilitators for incorporating complementary and integrative health interventions into routine clinical care. The study emphasizes that successful integration requires participatory approaches and significant adjustments to clinic workflows.

The article was published online ahead of print in Pain Management Nursing.

GRACE, an NIH Collaboratory Trial, is a pragmatic clinical trial embedded in 3 large healthcare systems to assess the effectiveness of guided relaxation and acupuncture treatments to improve pain control for patients with sickle cell disease. While clinical guidelines promote nonpharmacological treatments to reduce reliance on opioids, integrating therapies like acupuncture and guided relaxation into standard practice remains challenging.

The researchers conducted in-depth interviews with 13 hematologists, nurses, and pharmacists at GRACE trial sites. Two primary themes emerged: the variable impact on clinic operations, and the requirements for introducing complementary and integrative health interventions into clinical practice.

Participants noted that even minor changes can disrupt complex clinic workflows. Specifically, they identified the need for flexible or extended clinic hours to accommodate multiweek courses of acupuncture, as well as space for administering treatments without interrupting other patient visits. Participants also noted that clinics would benefit from streamlined ordering processes to avoid administrative burdens.

The study highlighted a significant need for patient and clinician education. While evidence exists for complementary and integrative health interventions, many clinicians remain hesitant to recommend them due to knowledge gaps. Patients may also feel wary of new therapies, necessitating clear, accessible educational tools like videos, apps, and brochures.

GRACE is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Center for Complementary and Integrative Health. Learn more about GRACE.

January 12, 2026: Enhanced Acupuncture Strategy Found to Be Cost-Saving in Older Adults With Chronic Low Back Pain

Posted on January 12, 2026 by Damon Seils

Logo for the BackInAction trial An economic evaluation from the BackInAction trial found that an enhanced course of acupuncture for older adults with chronic low back pain was cost-saving from both the Medicare and healthcare sector perspectives.

The article appears in the upcoming issue of Spine.

In a previously published report, the BackInAction research team established that acupuncture significantly improved pain and disability in patients aged 65 years and older. The new analysis shows the treatment also provides significant value to the healthcare system.

The cost-effectiveness analysis, led by Patricia Herman of the RAND Corporation, analyzed data for 672 participants across 3 large healthcare systems. The study compared 3 treatment strategies: a standard 12 -week course of acupuncture plus usual medical care; standard acupuncture enhanced with up to 6 maintenance sessions plus usual care; and usual care alone.

The research team found that enhanced acupuncture reduced annual back pain–related healthcare costs by an average of $491 per participant and reduced Medicare-reimbursed costs by $421 per participant compared with usual care alone. The savings were primarily driven by a significant reduction in non-acupuncture healthcare utilization.

BackInAction, an NIH Collaboratory Trial, was led by co–principal investigators Lynn DeBar of the Kaiser Permanente Center for Health Research and Andrea Cook of the Kaiser Permanente Washington Health Research Institute.

Read the full report.

Beyond financial savings, participants in the enhanced acupuncture group experienced:

Significant gains in quality-adjusted life-years, a standard measure of health-related quality of life
An 18.5 percentage-point increase in the number of participants achieving a clinically meaningful improvement in their disability scores

While standard acupuncture was slightly more expensive than usual care, the strategy’s incremental cost-effectiveness ratio of approximately $53,000 per quality-adjusted life-year suggests it may be cost-effective from the perspectives of Medicare and the healthcare sector.

The BackInAction team’s findings are particularly relevant in the context of the Medicare program’s decision in 2020 to begin covering acupuncture for chronic low back pain. The study suggests that the current Medicare benefit, which includes maintenance sessions, aligns with the most cost-effective and beneficial care for this population.

By including a variety of healthcare settings and older adults with multiple medical conditions, this pragmatic clinical trial’s results are intended to be highly generalizable and to inform future treatment policies for the millions of older people in the United States who experience chronic pain.

BackInAction was supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Center for Complementary and Integrative Health. Learn more about BackInAction.

January 8, 2026: Study Design Paper Published for BEST-ICU

Posted on January 8, 2026January 8, 2026 by Damon Seils

Headshots of Dr. Michele Balas and Dr. Eduard Vasilevskis — Dr. Michele Balas and Dr. Eduard Vasilevskis, principal investigators for BEST-ICU

The study design paper for BEST-ICU has been published online in Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The BEST-ICU trial is evaluating 2 strategies grounded in behavioral economics theory and implementation science to increase adoption of the ABCDEF bundle in the intensive care unit and improve care for critically ill adults across a variety of healthcare systems. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care.

The study is being led by Eduard Vasilevskis of the University of Wisconsin and Michele Balas of the University of Nebraska and is supported by a grant award from the National, Heart, Lung, and Blood Institute.

Read the full study design paper.

December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory

Posted on December 15, 2025January 9, 2026 by Damon Seils

A collage of journal covers with the label "NIH Pragmatic Trials Collaboratory 2025 Publications Roundup" In 2025, NIH Pragmatic Trials Collaboratory investigators published new study designs and trial results, shared insights from program leadership, and developed innovative methods in the design, conduct, implementation, and dissemination of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed 45 articles to the peer-reviewed literature this year, including the primary results of the ACP PEACE, BackInAction, HiLo, INSPIRE, and PRIM‑ER trials. Cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program reached 386.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Distributed Research Network

Generating real-world evidence in early Alzheimer's disease: Considerations for applying the target trial emulation framework to study the safety of anti-amyloid therapies

Core Working Groups

Ethics and Regulatory Core

Health Care Systems Interactions Core

Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

Patient-Centered Outcomes Core

Collection of patient-reported outcome measures in rural and underserved populations